Holding zone for intravascular medical device

ABSTRACT

A catheter that includes storage for an embolic protection device in an accessible, out-of-the-way location within the advancing catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/746,429, filed on Jan. 22, 2013, which is a continuation of U.S.patent application Ser. No. 12/620,212, filed on Nov. 17, 2009, now U.S.Pat. No. 8,435,256, which is a continuation of U.S. patent applicationSer. No. 10/810,445, filed on Mar. 26, 2004, now U.S. Pat. No.7,637,920, which claims the benefit of, and priority to, U.S.Provisional Pat. Application Ser. Nos. 60/508,437 and 60/458,884, filedon Oct. 3, 2003 and Mar. 28, 2003, respectively, the entire content ofeach of the applications identified above being incorporated byreference herein.

FIELD OF THE INVENTION

The present invention is related generally to medical devices. Morespecifically, the present invention is related to intravascular medicaldevices such as catheters and guidewires.

BACKGROUND OF THE INVENTION

Blood vessel disease is a significant cause of premature disability anddeath. Heart attacks, strokes and other ailments are often caused byblood vessel disease.

The most common disease of the blood vessels is atherosclerosis.Atherosclerosis involves the accumulation of plaques of cholesterol,lipids and cellular debris within an artery. As the plaque accumulates,the artery wall thickens thereby narrowing the lumen of the artery. Asthe lumen narrows, the blood flow to tissue nourished by the artery isdiminished. The development of plaques can also contribute to theformation of emboli or thrombi. An embolus is a moving obstruction suchas a platelet aggregate. A thrombus can be a fixed obstruction such as awall adherent blood clot or can become an embolus. A thrombus or emboluswithin a coronary artery can occlude the artery thereby causingmyocardial infarction, angina and other conditions. A blockage caused bya thrombus or embolus within a vessel supplying blood to the brain canlead to a stroke. Renal, peripheral, and other blood vessels can alsobecome blocked by an embolus or a thrombus thereby causing tissue damagedownstream of the blockage.

A number of medical procedures have been developed to allow for theremoval of plaque from vessel walls or to clear a channel throughplaque, thrombus or clot to restore blood flow. For example, atherectomyor thrombectomy devices can be used to remove atheroma or thrombus.Vessel restrictions can also be treated with grafts that bypass therestrictions. Alternatively, balloon angioplasty and stenting procedurescan be used to enlarge the lumen size of a vessel at an obstruction.

In a typical angioplasty procedure, a guide wire and guide catheter areinserted into a vessel of a patient. An inflatable balloon is thenpushed through the guide catheter and advanced across a stenosis orblockage. Once positioned at the blockage, the balloon is inflated todilate the blockage and open a flow channel through the partiallyblocked vessel region. One or more stents may also be placed across thedilated region or regions to reinforce the expanded vessel segment or tomaintain dilatation of a vessel segment.

While some stenoses remain adherent to the vessel wall during treatment,others are more brittle, and may partially crack and fragment duringtreatment, allowing the fragments to flow downstream where they mayblock more distal and smaller vessels. Consequences of embolizationinclude myocardial infarction, stroke, diminished renal function, andimpairment of peripheral circulation possibly leading to pain andamputation.

Embolic protection devices have been developed to prevent the downstreamtravel of materials such as thrombi, grumous, emboli, and plaquefragments. Devices include occlusive devices and filters and may bedeployed distal to a treatment site or proximal to a treatment site.Occlusive devices, for example distal inflatable balloon devices, cantotally block fluid flow through the vessel. The material trapped by theinflatable devices can remain in place until removed using a method suchas aspiration. Occlusive devices can also be deployed proximal to atreatment site and flow reversed or stopped at the treatment site.Following treatment emboli are carried by flow out of the vesseltypically through a catheter and out of a patient. Filters can allowperfusing blood flow during the emboli capture process. The filters canbe advanced downstream of a site to be treated and expanded to increasethe filter area. Emboli, such as grumous or atheroma fragments, can becaptured in the filter until the procedure is complete or the filter isoccluded. When the capacity of the filter is reached, the filter maythen be retracted and replaced.

Embolic protection devices can be delivered over guide wires and withinguide catheters. The embolic protection methods are normally practicedancillary to another medical procedure, for example angioplasty withstenting or atherectomy. The embolic protection procedure typicallyprotects downstream regions from emboli resulting from practicing thetherapeutic interventional procedure.

SUMMARY OF THE INVENTION

One inventive aspect of the present disclosure relates to a medicaldevice comprising an elongated member configured to be advanced along avascular path of a patient, the elongated member having opposite firstand second ends, the first end and second ends both being adapted forintravascular insertion, and the first end having a different structurethan the second end. The elongated member has sufficient flexibility tobe advanced through a human vasculature. Preferably, the first andsecond ends are adapted to have different operating characteristics.

Depending on the operating characteristics needed for a particularprocedure, a physician can insert either the first end portion or thesecond end portion of the elongated member into the patient'svasculature. The intravascular medical device can include any number ofdifferent types of devices used in the treatment of vascular disease.Example devices include guide wires, catheters, embolic protectiondevice delivery systems and embolic protection device retrieval systems.

The invention provides a method for positioning a catheter within apatient's blood vessel, the method comprising: providing a cathetercomprising an elongated member configured to be advanced along avascular path of a patient, the elongated member having opposite firstand second ends, the first end and second ends both being adapted forintravascular insertion, the first end comprising a delivery sheath, thesecond end comprising a retrieval sheath, the delivery sheath comprisingat least one sidewall port adapted for receiving a wire, and thecatheter having a lumen between the first end and the at least onesidewall port; providing a guide wire having a proximal end and a distalend; advancing the guide wire to a target site within the patient'sblood vessel; and advancing the catheter over the guide wire byinserting the guide wire through the catheter lumen between the firstend and the at least one sidewall port.

The invention provides a guide wire loading assist device comprising: amember having a proximal first and a distal second end and a lumen therebetween, the lumen being adapted to encase a catheter having a sidewallport adapted for receiving a wire; and a sidewall port in the memberadapted for receiving a wire, wherein the lumen of the member has afirst axial orientation from the proximal first end to the sidewall portof the member and a second axial orientation from the sidewall port ofthe member to the distal second end, the different axial orientationsforming a bend in the lumen near the sidewall port, the sidewall port ofthe member being adapted to be coincident with the sidewall port of thecatheter.

The invention also provides a catheter that provides storage for anembolic protection device in an accessible, out-of-the-way locationwithin the advancing catheter. In one embodiment, the catheter comprisesan elongate tubular body having a proximal portion, a distal portion, aproximal end, a distal end, a lumen extending between the proximal endand the distal end, and a tube wall disposed about the lumen. A firstport is disposed in the distal portion of the tubular body anddimensioned to receive a guide wire therethrough, and the first port isformed through the tube wall. The lumen of the tubular body has a firstinner diameter at the first port and a second, reduced inner diameter ata point proximal of the first port.

The invention also provides a method for positioning a catheter within apatient's blood vessel, the method comprising: providing a catheterdescribed herein; providing a guide wire having a proximal end and adistal end; advancing the guide wire to a target site within thepatient's blood vessel; and advancing the catheter over the guide wireby inserting the guide wire through the catheter lumen between thedistal end and the first port.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows a medical device having features that areexamples of inventive aspects in accordance with the principles of thepresent disclosure.

FIG. 2 shows a double-ended catheter having features that are examplesof inventive aspects in accordance with the principles of the presentdisclosure.

FIG. 3 shows the catheter of FIG. 2 with a delivery end of the cathetercontaining an emboli protection device, the delivery end is locatedadjacent to an ostium.

FIG. 4 shows the delivery end of the catheter of FIG. 2 at a targetsite.

FIG. 5 shows the emboli protection device of FIGS. 3 and 4 deployed atthe target site.

FIG. 6 shows the catheter of FIG. 2 with a retrieval end of the catheterin close proximity to the deployed emboli protection device of FIG. 5.

FIG. 7 shows the emboli protection device of FIG. 6 captured within theretrieval end of the catheter of FIG. 2.

FIG. 8 shows an alternative double-ended catheter.

FIG. 9 is a cross-sectional view taken along section line 9-9 of FIG. 8.

FIG. 10 shows another alternative double-ended catheter.

FIG. 11 is a cross-sectional view taken along section line 11-11 of FIG.10.

FIG. 12 shows a double-ended catheter that includes an expandableballoon.

FIG. 12A is a detailed view of a portion of FIG. 12.

FIG. 12B is an alternative balloon catheter configuration.

FIGS. 13-15 show a technique for equipping the catheter of FIG. 12 witha Luer fitting for use in inflating and deflating the expandableballoon.

FIGS. 16 and 17 show packaging techniques for protecting the deliveryend of the catheter of FIG. 2 during shipping.

FIG. 18 shows an alternative double-ended catheter.

FIGS. 19 and 19A show a guide wire loading assist device disposed on analternative double-ended catheter.

FIGS. 19B and 19C show an alternate embodiment of a guide wire loadingassist device.

FIG. 20 shows an embolic protection device delivery/recovery catheterwith a constriction in the inner diameter of the catheter proximal of aguide wire exit port and proximal of a distal exit port.

FIG. 21A shows an embolic protection device delivery/recovery catheterwith a toroid insert sized to fit the inner diameter of the catheter atthe location indicated in FIG. 20.

FIG. 21B shows an embolic protection device delivery/recovery catheterwith a tubular insert sized to fit the inner diameter of the catheter.

FIG. 21C shows an embolic protection device delivery/recovery catheterwith a tubular insert sized to fit the inner diameter of the catheterand a reinforced catheter shaft.

FIG. 21D shows an embolic protection device delivery/recovery catheterwith an alternate tubular insert sized to fit the inner diameter of thecatheter.

FIG. 21E shows an end view of the tubular insert shown in FIG. 21D.

FIG. 21F shows an alternate tubular insert sized to fit the innerdiameter of the catheter.

FIG. 21G shows an embolic protection device delivery/recovery catheterwith an alternate constriction in the inner diameter of the catheterproximal of a guide wire exit port and proximal of a distal exit port.

FIG. 21H shows an end view of the alternate constriction in the innerdiameter of the catheter shown in FIG. 21G.

FIG. 21I shows an embolic protection device delivery/recovery catheterwith an alternate constriction in the inner diameter of the catheterproximal of a guide wire exit port and proximal of a distal exit port.

FIG. 21J shows an end view of the alternate constriction in the innerdiameter of the catheter shown in FIG. 21.

FIG. 21K shows an isometric view of an alternate construction of atoroid insert sized to fit the inner diameter of the catheter shown inFIG. 21A.

FIG. 21L shows an isometric view of an alternate construction of atoroid insert sized to fit the inner diameter of the catheter shown inFIG. 21A.

FIG. 21M shows an isometric view of an alternate tubular insert sized tofit the catheter shown in FIG. 21D.

FIG. 22 shows an embolic protection device delivery/recovery catheterwith a funnel-shaped insert having its larger outer diameter sized tofit the inner diameter of the catheter at the location indicated in FIG.20, with the smaller funnel diameter facing proximally.

FIG. 23 shows an embolic protection device delivery/recovery catheterwith a funnel-shaped insert as illustrated in FIG. 22, with the smallerfunnel diameter facing distally.

FIG. 24 shows an embolic protection device delivery/recovery catheterwith an abrupt change in inner diameter.

FIG. 25 shows an embolic protection device delivery/recovery catheterwith a gradual change in inner diameter.

FIG. 26A shows an embolic protection device delivery/recovery catheterwith a change in inner diameter and a proximal shaft stiffener.

FIG. 26B shows a section view of the catheter shown in FIG. 26A.

FIG. 26C shows an alternate construction of an embolic protection devicedelivery/recovery catheter with a change in inner diameter and aproximal shaft stiffener.

FIG. 26D shows a section view of the catheter shown in FIG. 26C.

FIG. 27A shows an embolic protection device delivery/recovery catheterwith a toggle stop and a distal reduced diameter region.

FIG. 27B shows a section view of the catheter shown in FIG. 27A.

FIGS. 27C and 27D show an embolic protection device delivery/recoverycatheter with a toggle stop and a distal reduced diameter region with anembolic protection device within the catheter.

DETAILED DESCRIPTION OF THE INVENTION

Inventive aspects of the present disclosure relate to intravascularmedical devices having opposite end portions each adapted for insertionwithin the vasculature of a patient. The opposite end portions each havedifferent operating characteristics such that the medical device iscapable of performing different functions depending upon the end of thedevice that is inserted into the patient. It will be appreciated thatthe broad aspects of the present invention are applicable to any numberof different types of intravascular medical devices. Example devicesinclude guide wires, catheters, implant delivery systems, emboliprotection device delivery systems, implant retrieval systems, andemboli protection device retrieval systems.

The components of the catheters of the invention are made frombiocompatible materials such as metals or polymeric materials. Ifnecessary, these metals or polymeric materials can be treated to impartbiocompatibility by various surface treatments, as known in the art.Suitable materials include stainless steel, titanium and its alloys,cobalt-chromium-nickel-molybdenum-iron alloy (commercially availableunder the trade designation ELGILOY™), carbon fiber and its composites,and polymers such as liquid crystal polymers, polyetheretherketone(PEEK), polyimide, polyester, high density polyethylene, PEBAX®, variousnylons, and the like. A shape memory or superelastic material such asnitinol or shape memory polymer is also suitable. The size, thickness,and composition of materials are selected for their ability to performas desired as well as their biocompatibility. It is to be understoodthat these design elements are known to one of skill in the art.

With reference now to the various drawing figures in which identicalelements are numbered identically throughout, a description is providedof embodiments that are examples of how inventive aspects in accordancewith the principles of the present invention may be practiced. It willbe appreciated that the depicted embodiments are merely exemplary, andare not intended to limit the broad scope of the present invention.

I. General Double Ended Device

FIG. 1 illustrates an intravascular medical device 20 having featuresthat are examples of inventive aspects in accordance with the principlesof the present disclosure. It will be appreciated that the intravascularmedical device 20 can be embodied in a number of different devices suchas catheters, guide wires, embolic filter delivery devices, embolicfilter retrieval devices, as well as other devices.

Referring to FIG. 1, the medical device 20 includes an elongated body 22having first and second opposite end portions 24, 26. The elongated body22 is preferably sufficiently flexible to allow the device to beadvanced through a curving vascular pathway without kinking and withoutpuncturing the vessel wall. The first and second end portions 24 and 26are both capable of leading the elongated member 22 through thevasculature depending upon the direction the elongated member 22 isinserted into the vasculature. The first and second end portions 24 and26 preferably have different operating characteristics. For example, inone embodiment, the first end portion 24 can be more flexible than thesecond end portion 26. In other embodiments, the first and second endportions 24 and 26 can have different pre-formed shapes adapted forfacilitating advancement of the medical device 20 along differentintravascular pathways. In still other embodiments, the first and secondend portions 24 and 26 can be adapted for providing different functions.For example, in one embodiment, the first end portion 24 can be adaptedfor deploying an indwelling medical device such as a stent, graft orembolic protection device, and the second end portion 26 can be adaptedfor retrieving an indwelling medical device such as a stent, graft orembolic protection device.

The elongated member 22 of the medical device 20 includes a main body 28that extends between the first and second end portions 24 and 26. Themain body 28 can have any number of different types of configurations.For example, the main body 28 can have a solid configuration such as asolid wire configuration, a solid polymeric configuration, or acomposite metal and polymeric configuration. In other embodiments, theelongated member 22 can have a tubular configuration defining a singlelumen, or can define a plurality of lumens. In one embodiment, the mainbody 28 includes a metal having “super elastic” properties such asnitinol. The main body 28 can also include materials such as carbonfiber and its composites, liquid crystal polymers, ceramics, andcomposites in general. The elongated member may be coated withhydrophobic, hydrophilic, or biologically active coatings such as polyvinyl pyrrolidone coatings, ePTFE coatings, or heparin coatings. In onenon-limiting embodiment, the elongated member 22 has a length L in therange of 60-300 cm, and an outer diameter D in the range of 0.013″ to0.100″ (0.033 to 0.25 cm).

The end portions 24 and 26 of the medical device can have any number ofdifferent configurations. For example, end portions 24 and 26 caninclude a polymeric material, a metal material, a combined polymer andmetal material, a shape memory material, or a super elastic material.Further, the end portions 24, 26 can include a solid configuration, or atubular configuration defining a single lumen or a multi-lumenconfiguration. Moreover, the end portions 24 and 26 can include constantdiameter embodiments, tapered diameter embodiments, solid wall tubularembodiments, perforated wall tubular embodiments, slotted-wall tubularembodiments, coiled embodiments, and any number of other differentconfigurations. The first and second end portions 24 and 26 can beunitary parts of the main body 28, or can be separate pieces orcomponents that are affixed to the main body 28. It will be appreciatedthat the lengths and diameters of the end portions 24, 26 will varydepending upon their desired operating characteristics. In oneembodiment, the end portions 24, 26 function as flexible guide tipshaving greater flexibility than the main body 28, and differentflexibilities from one another.

II. Double Ended Catheter with Rapid Exchange Features

FIG. 2 illustrates a catheter 100 having features that are examples ofinventive aspects in accordance with the principles of the presentdisclosure. The catheter 100 includes a central shaft 110 having a firstend 112 positioned opposite from a second end 114. A tip in the form ofa flexible delivery sheath 116 is positioned at the first end 112. Theflexible delivery sheath 116 defines an internal pocket 118 (i.e., acompartment, cavity, enclosure, chamber or receptacle) configured forreceiving a preloaded device (e.g., a preloaded embolic protectiondevice such as the filter device 70 shown in FIGS. 3-5). The catheter100 also includes a flexible retrieval sheath 120 positioned at thesecond end 114 of the shaft 110. The flexible retrieval sheath 120defines an internal pocket 122 sized and shaped for receiving a medicaldevice (e.g., an embolic protection device such as the filter device 70of FIGS. 3-5) for retrieval of the medical device after the device hasbeen used.

The shaft 110 of the catheter 100 is preferably sufficiently flexibleand has sufficient column strength to be advanced through thevasculature of a patient. In a preferred embodiment, the shaft 110includes a solid wire coated with an outer layer of a polymericmaterial. However, it will be appreciated that in other embodiments, theshaft could include a tubular metal configuration or otherconfigurations. In one non-limiting embodiment adapted for use incoronary applications, the shaft 110 can have a length in the range of70-170 cm, and more preferably in the range of 100-140 cm. In certainembodiments, the shaft 110 can have an outer diameter D in the range of0.026″-0.040″ (0.066-0.10 cm).

Referring still to FIG. 2, the delivery sheath 116 of the catheterpreferably includes a material that is softer and more pliable than thecentral shaft 110. The flexible design of the delivery sheath 116facilitates advancing the catheter 100 through tortuous vessels whilethe more rigid central shaft 110 can provide pushability. In a preferredembodiment, the delivery sheath 116 is formed of a polymer such as LDPE,MDPE, or PEBAX. In one embodiment, the outer diameter of the deliverysheath can be in the range of 0.026-0.040 inches (0.066-0.10 cm), a wallthickness of the delivery sheath can be in the range of 0.001 to 0.005inches (0.0025 to 0.013 cm), and a length of the delivery sheath can bein the range of 10 to 40 centimeters.

Referring still to FIG. 2, the delivery sheath 116 includes a firstsidewall port 148 and a second sidewall port 150. The first and secondsidewall ports 148, 150 are spaced apart from one another along thelength of the sheath 116. The first sidewall port 148 is located closerto a free end of the sheath 116 than the second sidewall port 150. Theports 148, 150 are preferably skived and dimensioned to allow a distallyand inwardly extending wire to extend from the outside of the sheath 116to the internal pocket 118 at an angle of less than about 10° relativeto a longitudinal axis of the catheter 100. Further details regardingthe configuration of the flexible sheath can be found in U.S. PatentApplication Publication No. 2003/0233117 A1, published Dec. 18, 2003,entitled RAPID EXCHANGE CATHETERS USABLE WITH EMBOLIC PROTECTIONDEVICES, the contents of which are hereby incorporated by referenceherein.

The recovery sheath 120 of the catheter 100 is preferably made of acompliant material that is more flexible than the shaft 110. Preferably,the sheath 120 has sufficient flexibility to allow the sheath 120 totraverse the tortuous pathways typically encountered within thevasculature of a human. Suitable materials for making the sheath 120include thermal plastic polymers, polymer blends and thermal setpolymers such as silicone, or silicone blends with a low durometer. Onesuch material is a 35/40 D PEBAX blend. Any other appropriate compliantmaterials may, however, be used. In one embodiment, the outer diameterof the recovery sheath can be in the range of 0.040-0.060 inches (0.10to 0.15 cm), a wall thickness of the recovery sheath can be in the rangeof 0.001 to 0.005 inches (0.0025 to 0.013 cm), and a length of therecovery sheath can be in the range of 5 to 30 centimeters.

Referring still to FIG. 2, the recovery sheath has an outermost end thatforms a rolled tip 132. The rolled tip 132 is especially designed forcrossing a stented or otherwise constricted region of a blood vessel.The rolled tip 132 can also function to capture an implanted device suchas an embolic protection device. Further details regarding the recoverysheath 120 can be found in U.S. Patent Application Publication No.2002/0111649 A1, published Aug. 15, 2002, entitled ROLLED TIP RECOVERYCATHETER, the contents of which are hereby incorporated by referenceherein.

In certain embodiments, the sheaths 116, 120 can include one or morebands of radiopaque material, or can be filled with radiopaque material.Examples of radiopaque materials include barium sulfate, bismuth subcarbonate, tungsten powder, and the like. The presence of radiopaquematerials facilitates viewing the sheaths under fluoroscopy. The sheaths116, 120 may be coated with hydrophobic, hydrophilic, or biologicallyactive coatings such as poly vinyl pyrrolidone coatings, ePTFE coatings,or heparin coatings.

Use of the catheter 100 will now be described with respect to a coronaryprocedure. However, it will be appreciated that the embodiment can alsobe used for treating other vessels (e.g., carotid, renal, peripheral,and other blood vessels).

In an example of a coronary procedure, a physician first inserts aguidewire (not shown) into the femoral artery of a patient near thegroin, and advances the guidewire through the artery, over the aorta andto a coronary ostium 21. Once the guidewire is in place, a guidecatheter 11 is passed over the guidewire and advanced until a distal endof the guide catheter 11 is located adjacent the coronary ostium 21. Theguidewire (not shown) is then removed. With the guide catheter 11 inplace, a coronary guidewire 19 is inserted into the guide catheter andadvanced into the coronary artery. See FIG. 3. Next, the proximal end ofthe coronary guidewire 19 is inserted (i.e. back-loaded) through thedistal opening of sheath 116 and then the first sidewall port 148 of thedelivery catheter 100.

Prior to insertion of the coronary guidewire 19 through the firstsidewall port 148, an embolic protection device such as an embolicfilter device 70 is preferably pre-loaded within the delivery sheath 116of the catheter 100. The filter device 70 is preferably aself-expandable filter device such as the filter device disclosed inU.S. Pat. No. 6,325,815, the contents of which are hereby incorporatedby reference herein. The filter device 70 includes an expandable filtermesh 71 secured to the distal end of a host wire 74. As shown in FIG. 3,in the pre-loaded configuration, the mesh of the filter device iscompressed in a radially reduced profile configuration within thedelivery sheath 116, and the host wire 74 extends from the mesh materialthrough the second sidewall port 150 of the delivery sheath 116. Thefilter device 70 can be viewed as one type of distal emboli protectionelement. Other distal protection elements which can be included as partof the device are occlusive emboli protection elements, includingexpandable or inflatable elements for blocking fluid flow through avessel.

After the guide wire 19 has been back-loaded through the delivery sheath116, the delivery sheath 116 of the catheter 100 is advanced through theguide catheter 11 along the guidewire 19 until the delivery sheath 116is advanced to the distal tip the guide catheter 11, as shown in FIG. 3.Preferably, the guidewire 19 is then further advanced within thecoronary artery to a point where the distal most tip of the guidewire 19is located at a target site 25 within a coronary artery 23 (e.g., a sitelocated downstream of a treatment site such as an occlusion 27). Thedelivery sheath 116 of the catheter 100 can then be tracked along theguide wire 19 to the target site 25 as shown in FIG. 4. In othermethods, the guidewire 19 and the catheter 100 can be advanced togetheracross the target site with the guidewire 19 providing stiffening forthe catheter 100.

Once the tip of the delivery sheath 116 is located at the target site25, the guidewire 19 is retracted proximally through the distal sidewallport 148. With the guidewire no longer present within the deliverysheath 116, the filter device 70 can be distally advanced to the tip ofthe delivery sheath 116 and then from the delivery sheath 116. Forexample, the embolic filter 70 can be advanced from the sheath 116 byproximally retracting the catheter 100 while the host wire 74 is held inplace by the treating physician. By retracting the catheter 100, thesheath 116 retracts relative to the filter device 70 thereby exposingthe filter device 70 and allowing the filter device 70 to expandradially so as to provide filtration across the entire cross sectionalarea of the vessel as shown in FIG. 5.

Once the filter device 70 is in place, the catheter 100 can be retractedfrom the patient, and an interventional device (e.g., a balloonangioplasty catheter, a stent delivery catheter, an atherectomy device,a thrombectomy device or any other device) can be introduced over thehost wire 74 and used to treat the treatment site. As the treatment siteis treated, any emboli generated during the treatment process arecaptured by the filter 70.

After the treatment process has been completed, the interventionaldevice is removed and the catheter 100 is reintroduced over the hostwire 74. However, when reintroduced, the catheter 100 is reversed suchthat the recovery sheath 120 functions as the distal most tip of thecatheter 100. Preferably, the host wire 74 is passed through theinterior of the recovery sheath 120 as shown in FIG. 6. The catheter 100is advanced until the rolled end 132 is positioned immediately proximalto the filter device 70. The host wire 74 is then pulled in a proximaldirection causing a proximal end of the filter device 70 to contact therolled tip 132. As the filter device 70 contacts the rolled tip 132, therolled tip 132 is urged elastically toward an open orientation in whichthe filter device 70 can be passed into the recovery sheath 120. Oncethe filter device 70 has been fully drawn into the sheath 120 as shownin FIG. 7, the rolled tip 132 reaches a point where it ceases to beengaged by the filter device 70, and it elastically returns to itsundeflected configuration. It will be appreciated that the resilientmaterial forming the sheath 120 prevents the escape of emboli when thefilter device 70 is captured. Preferably, at least a portion of the wallof the sheath 120 closely encompasses the periphery of the filter device70 and assumes the shape of the periphery. As a result, emboli areprevented from passing between the periphery of the filter device 70 andthe wall of the sheath 120. Alternatively, the filter device 70 can bepartly drawn into the recovery sheath 120 such that only the enlargedproximal opening of the filter is within the sheath.

Once the filter device is positioned within the recovery sheath 120,both the host wire 74 and the catheter 100 can be withdrawn from thepatient together as a unit. Thereafter, the procedure is completed byremoving the guide catheter 22 from the patient.

III. Over-the-Wire Double Ended Catheter

FIGS. 8 and 9 illustrate an alternative catheter 200 having a similarconfiguration as the catheter 100 of FIG. 2, except the solid centralshaft 110 has been replaced with a double lumen configuration 210 havinga first end 212 and a second end 214. The catheter 200 includes adelivery sheath 116 positioned at the first end 212 and a recoverysheath 120 positioned at the second end 114. The double lumenconfiguration 210 includes a first tube 211 that is coaxial with thedelivery sheath 116, and a second tube 213 that is coaxial with therecovery sheath 120. It will be appreciated that the tubes of the doublelumen configuration 210 are coupled together and are sufficientlyflexible to be able to be passed through a tortuous vascular pathway,and also have sufficient column stiffness to allow the catheter 200 tobe pushed through the vasculature. It will be appreciated that the tubescan be manufactured using any number of known techniques. For example,the tubular structures may be extruded or coextruded in the crosssectional shape shown in FIG. 9 or in any number of alternative crosssections, for example those known in the art as double D, smile, orother configurations. Alternatively, the tubular structures can bemanufactured from individual tubes of polymer such as polyimide or asuper elastic material such as nitinol and held together with adhesivesor a thin tube that surrounds both single lumen tubes. It will beappreciated that any number of different types of material can be usedto form double lumen configuration 210.

Similar to the previous embodiment, the catheter 200 can be used to bothdeliver a device such as an embolic protection device, and to retrieve adevice such as an embolic protection device. The catheter 200 is used ina manner similar to the catheter 100, except the catheter 200 does nothave rapid exchange capabilities. Instead, when the catheter 200 is usedwith the delivery sheath 116 as the distal end, a guidewire is passedthrough the entire length of the first tube 211. Similarly, when theretrieval sheath 120 is used as the distal end of the catheter 200, aguidewire or wire such as host wire 74 is passed completely through thesecond tube 213 of the double lumen configuration 210.

IV. Double Ended Catheter with Combined Rapid Exchange and Over-the-WireConfiguration

FIGS. 10 and 11 illustrate another catheter 300 having features that areexamples of inventive aspects in accordance with the principles of thepresent disclosure. Similar to the previous embodiments, the catheter300 includes a delivery sheath 116 positioned at one end, and a recoverysheath 120 positioned at the opposite end. The delivery sheath 116 andthe recovery sheath 120 are interconnected by an elongated centralstructure 310 that includes a solid shaft 350 coupled to a tubular shaft352. The solid shaft 350 is connected to the recovery sheath 120, andthe tubular shaft 352 is connected to the delivery sheath 116. Theelongated central structure is sufficiently flexible to bend through thecontours of a tortuous vascular pathway, and also include sufficientcolumn strength to allow the catheter 300 to be pushed through thepathway. The tubular shaft structure 352 has a central lumen in fluidcommunication with the pocket 118 of the delivery sheath 116.

It will be appreciated that the catheter 300 can be used to deliverdevices such as embolic protection devices in much the same way as theprevious two embodiments. However, when delivering an embolic protectiondevice using the delivery sheath 116, the delivery sheath 116 as well asthe entire tubular shaft 352 would typically be passed over a guidewire.In contrast, when the catheter 300 is used as a retrieval device, thecatheter 300 can be used as a rapid exchange catheter in which aguidewire or wire is not passed through the entire catheter, but insteadonly passes through the distal tip (e.g., the recovery sheath portion120 of the catheter).

V. Double Ended Catheter with Balloon

FIG. 12 shows another catheter 400 having features that are examples ofinventive aspects in accordance with the principles of the presentdisclosure. The catheter 400 includes a delivery sheath 116 positionedat one end and a recovery sheath 120 positioned at the opposite end. Thedelivery sheath 116 and the recovery sheath 120 are interconnected by acentral elongated member 410. The elongated member 410 includes a solidshaft 411 connected to the recovery sheath 120, and a tubular shaft 413connected to the delivery sheath 116. The tubular shaft 413 defines acentral lumen 415 that extends from a first end 417 of the tubular shaftto the delivery sheath 116. The lumen is preferably sealed so as to notbe in fluid communication with the interior of the delivery sheath 116.The delivery sheath 116 includes a guidewire port 148 and a host wireport 150.

Referring still to FIG. 12, a balloon such as an angioplasty balloon ora low pressure occlusion balloon 419 is provided on the tubular shaft413 adjacent to the delivery sheath 116. The balloon 419 is in fluidcommunication with the lumen 415 of the tubular shaft 413. The first end417 of the tubular shaft 413 is sealed by a septum or other seal 421.The septum or seal 421 can include multiple membranes 421 a, 421 b (seeFIG. 12A) bonded together at a perimeter of the membranes. The membrane421 a can have a self-closing slit 425 while membrane 421 b can have acentral hole that seals against a blunt needle. Either membrane can havea rim 427 that can be sealed to lumen 415 of tubular shaft 413. Asyringe with a blunt needle can be used to inject fluid into the lumenthrough the seal 421 to inflate the balloon 419.

Other techniques can also be used to provide fluid into the lumen. Forexample, the first end 417 of the tubular shaft 413 can include a sideport in fluid communication with a Luer fitting. The Luer fittingprovides a connection location for attaching an inflation device. TuohyBorst fittings can be secured to the tubular shaft at locations distalto and proximal to the side port to provide a seal between the Luerfitting and the catheter body. The Tuohy Borst fittings can alsoreferred to as hemostatic valves.

Additionally, a Luer lock fitting can be used to provide fluid to thelumen 415. For example, as shown in FIG. 13, the tubular shaft 413 caninclude an elongated slot 433 adjacent the first end in which a Luerlock fitting 435 (shown in FIGS. 14 and 15) can be inserted. FIG. 14shows the Luer lock fitting 435 partially inserted within the slot 433.A stem 437 of the lock fitting 435 fits within the lumen 415.Preferably, the stem 437 snugly fits within the lumen 415 such thatfriction between the stem 437 and the wall of the tubular shaft 413function to provide a fluid tight seal about the stem 437. A rounded end439 of the lock fitting 435 also fits within the slot 433 such that theLuer fitting 435 snaps into a locked or seated position as shown in FIG.15. The Luer fitting 435 provides an attachment location for attaching aballoon inflation apparatus to the catheter.

It should also be appreciated that the balloon shown in FIG. 12 couldalternatively be positioned on the delivery sheath 116 of catheter 400by those skilled in the art. See, for example, FIG. 12B.

The catheter of FIG. 12B can be used in a manner that helps to preventdistal migration of emboli during embolic filter passage across atreatment site. For example, the catheter can be used as described forcatheter 100 in connection with FIGS. 3-7. However, the catheter ispreloaded with an actuator style embolic protection device such as thatdescribed in U.S. Pat. No. 6,520,978 B1, the contents of which arehereby incorporated by reference herein. Prior to crossing the treatmentsite, the catheter balloon 419 is inflated to a pressure sufficient tosubstantially impede blood flow across the treatment site. After ballooninflation, the guidewire 19 is withdrawn and the embolic filter isadvanced across the treatment site in a collapsed diameter. Importantly,emboli liberated by the embolic filter during treatment site passagecannot be transported distally because the inflated balloon 419 preventsdistal blood flow and distal transport of emboli within the flow stream.After crossing the treatment site, the actuating style filter isactuated to cause it to diametrically enlarge and position the filteracross the vessel cross sectional area. At this point, the balloon 419is deflated and flow is restored, causing emboli liberated duringtreatment site crossing to be transported to and captured by the filter.The catheter can now be removed and the treatment site treated.Alternatively, the catheter can be advanced and the balloon used totreat a lesion, followed by balloon deflation and capture of releasedemboli in the filter.

While a balloon has been shown, it will be appreciated that inalternative embodiments, the catheter could include openings fordelivering a substance (e.g., a medicine, dye, or other substance) tothe vasculature of a patient.

VI. Protective Packaging

FIG. 16 illustrates a system 600 for protecting the delivery sheath 116during shipping. The system includes an outer protective sheath 610mounted over the exterior of the delivery sheath 116. A stylette 615extends into the tip of the delivery sheath 116, through the firstsidewall port 148 and along the outer surface of the catheter. Thestylette provides rigidity for protecting the delivery sheath 116. Aloop 620 is provided for pulling the stylette 615 from the sheath 116.

FIG. 17 shows an alternative stylette 600′ having a flag 650 as comparedto a loop 620. Method of use instructions for the catheter can beprinted on the flag 650.

Alternatively the protective packaging can be applied to the recoverysheath 120, or to both the delivery sheath 116 and the recovery sheath120. It will be further appreciated that it is not necessary to utilizeboth a stylette and protective sheath; they can be used alone as well asin combination at either or both ends of the catheter.

VII. Double Ended Catheter with Rapid Exchange Features and VariableDiameter

FIG. 18 illustrates a catheter 700 similar to the catheter of FIG. 2.The catheter 700 includes a central shaft 710 having a first end 712positioned opposite from a second end 714. A tip in the form of aflexible delivery sheath 716 is positioned at the first end 712. Theflexible delivery sheath 716 defines an internal pocket 718 (i.e., acompartment, cavity, enclosure, chamber or receptacle) configured forreceiving a preloaded device (e.g., a preloaded embolic protectiondevice such as the filter device 770 shown in FIG. 18). The filterdevice 770 includes an expandable filter mesh 771 secured to the distalend of a host wire 774. The catheter 700 also includes a flexibleretrieval sheath 720 positioned at the second end 714 of the shaft 710.The flexible retrieval sheath 720 defines an internal pocket 722 sizedand shaped for receiving a medical device (e.g., an embolic protectiondevice such as the filter device 770 of FIG. 18) for retrieval of themedical device after the device has been used.

The delivery sheath 716 includes a first sidewall port 748 and a secondsidewall port 750. The first and second sidewall ports 748, 750 arespaced apart from one another along the length of the sheath 716. Thefirst sidewall port 748 is located closer to a free end of the sheath716 than the second sidewall port 750. The ports 748, 750 are preferablyskived and dimensioned to allow a distally and inwardly extending wireto extend from the outside of the sheath 716 to the internal pocket 718at an angle of less than about 10° relative to a longitudinal axis ofthe catheter 700.

The catheter 700 includes a lumen portion 740 of a narrower diameterthan the internal pocket 718. The diameter of the internal pocket 718 isreduced at constriction 744. Constriction 744 prevents proximal movementof the filter device 770 and creates a preloading stop or “holding zone”location for the filter device 770. This location is distal of theconstriction 744 and proximal of the first sidewall port 748 to preventinteraction of the guidewire 719 with the filter 770.

VIII. Guide Wire Loading Assist Device

FIGS. 19 and 19A illustrate a guide wire loading assist device 854. Thedevice 854 has a port 856 that lines up with sidewall port 748 ofcatheter 700. As shown in FIG. 19, assist device 854 bends catheter 700to make loading of the guide wire 719 easier. In some embodiments theassist device 854 bends catheter 700 by having a pre-formed shape andstiffness sufficient to overcome the shape and stiffness of catheter700. Specifically, the device 854 ensures that the guide wire will exitthe correct port without interacting with the filter 770.

The device 854 may be loaded prior to packaging or provided as aseparate piece within the packaging for the physician to place on thecatheter 700 prior to introducing the guide wire 719. A slit 858 thatruns from port 856 to the proximal end of the device 854 allows for easyremoval of the device once the guide wire is in place. Alternatively, aslit may run from port 856 to distal end of the device 854, or bothproximal and distal slits may be provided. In some embodiments, slotsare used rather than slits. In another embodiment a pull tab of a sizesufficient for a device user to grasp is provided at one or both ends ofdevice 854 for the purpose of facilitating device 854 removal fromcatheter 700. In some embodiments the device 854 is comprised of apolymer having bright color so as to facilitate rapid identification bythe device user. After the device 854 is removed, the catheter revertsto its original conformation.

The device 854 preferably is made of a heat formable material formedwith a slight bend. Suitable heat formable materials include polymerssuch as LDPE, MDPE, and PEBAX. The device 854 can also be injectionmolded.

FIGS. 19B and 19C illustrate an alternate embodiment of a guide wireloading assist device 854. The device 854 has a port 856 that lines upwith sidewall port 748 of catheter 700. As shown in FIG. 19, assistdevice 854 bends catheter 700 to make loading of the guide wire 719easier. In some embodiments the assist device 854 bends catheter 700 byhaving a preformed shape and stiffness sufficient to overcome the shapeand stiffness of catheter 700. Specifically, the device 854 ensures thatthe guide wire will exit the correct port without interacting with thefilter 770.

The device 854 may be loaded prior to packaging or provided as aseparate piece within the packaging for the physician to place on thecatheter 700 prior to introducing the guide wire 719. A slit 958 runsfrom port 856 to the distal end of the device 854 and allows for easyremoval of the device once the guide wire is in place. A slot runs froma location proximal to port 856 to a proximal end of the device 854. Theaxis of proximal slotted end of device 854 is oriented approximately 25°away from the axis of the device 854 in the region of port 856. Theproximal slotted end of device 854 functions as a pull tab of a sizesufficient for a device user to grasp for removal of device 854 fromcatheter 700. In some embodiments the device 854 is comprised of apolymer having bright color so as to facilitate rapid identification bythe device user. After the device 854 is removed, the catheter revertsto its original conformation.

VI. Holding Zone

This invention also provides catheters with a variable inner diameter ofthe catheter shaft spaced proximally of a guide wire exit port toprovide a location or “holding zone” for a distal embolic protectiondevice, such as an embolic filter device. The catheter retains thedevice in this location during distal advance to the desiredintravascular position. In its retained location, the device avoidsinterference with the guide wire, yet is readily available fordeployment when needed.

In one embodiment, the invention provides a catheter for theintravascular deployment of a medical device, the catheter comprising:an elongate tubular body having a proximal portion, a distal portion, aproximal end, a distal end, a lumen extending between the proximal endand the distal end, and a tube wall disposed about the lumen. A firstport is disposed in the distal portion of the tubular body anddimensioned to receive a guide wire therethrough, and the first port isformed through the tube wall. The lumen of the tubular body has a firstinner diameter at the first port and a second, reduced inner diameter ata point proximal of the first port.

The tip of the catheter may be a generally softer material so as to helpprevent damage to a vessel wall as the tip is advanced through thevasculature. Softer materials such as PEBAX®, nylon, rubbers, urethane,silicone, ethylene vinyl acetate, and the like may be attached to thecatheter by adhesives, overmolding, heat bonding, solvent bonding, andother techniques known in the art. The tip may have a geometry designedto assist with advancement of the catheter past intraluminalobstructions, such as any of those constructions contained within US2002/0111649, Rolled Tip Recovery Catheter, the contents of which arehereby incorporated herein in its entirety.

The distal embolic protection device delivery/recovery catheter 1010,1030, 1050, 1070, shown in the FIGS. 20 to 23 embodiments, has aconstriction or narrowing 1012, 1320, 1321, 1322, 1323, 1324, 1325,1052, 1072 in the inner diameter 1014, 1034, 1054, 1074 of the cathetershaft 1016, 1036, 1056, 1076 proximal of the distal exit port 1018,1038, 1058, 1078 and proximal of the guide wire exit port 1020, 1040,1060, 1080, respectively. The catheter 1010, 1030, 1050, 1070 isconstructed and designed for use with any suitable guide wire 1100. Theconstriction or narrowing 1012, 1320, 1321, 1322, 1323, 1324, 1325,1052, 1072 of the catheter inner diameter 1014, 1034, 1054, 1074,respectively, creates a preloading stop or “holding zone” location foran embolic protection device, such as an embolic filter 1102. Thislocation is distal of the constriction 1012, 1320, 1321, 1322, 1323,1324, 1325, 1052, 1072 and proximal of the guide wire exit port 1020,1040, 1060, 1080, respectively, to prevent interaction of the guide wire1100 with the filter 1102. The guide wire 1100 advances into the distalexit port 1018, 1038, 1058, 1078 and out through the guide wire port1120, 1040, 1060, 1080, respectively. The catheter 1010, 1030, 1050,1070 may have the filter 1102 or other device positioned or preloadedfor out-of-the-way, non-interfering storage before and during distaladvancement of the catheter 1010, 1030, 1050, 1070 over a primary guidewire 1100.

In FIG. 20, the shaft 1016 of the catheter 1010 has an indentation orreduction 1012 of both the inner 1014 and outer diameter 1015 proximalof both the distal exit port 1018 and the guide wire exit port 1020. Theproximal side of the indentation 1012 may be a gradual reduction 1017from the catheter shaft 16 full diameter, while the distal side of theindentation 1012 may be an abrupt or right-angled corner 1019 reduction.The constriction may also be reversed from the FIG. 20 embodiment, withthe indentation 1012 distal side having a gradual reduction 1017 fromthe catheter shaft 1016 full diameter, while the indentation 1012proximal side has an abrupt or right-angled corner 1019 reduction.Alternatively, both sides of the indentation 1012 may have a gradual oran abrupt reduction from the full diameter, or the constriction 1012 maybe formed by any type, shape or method that reduces the diameter of theshaft 1016. The catheter 1010 may be formed with this indentation 1012,for example, by heating and crimping a uniform diameter catheter shaft,for example, with a specially designed tool. Alternatively, a band orwire (not shown) may be slid over the catheter shaft and mechanicallydeformed by crimping or swaging to effect an indentation, with orwithout application of heat. This indentation 1012 creates a preloadingstop or “holding zone” location for an embolic protection device, suchas an embolic filter 1102. The location is distal of the indentation1012 right-angled corner 1019 and proximal of the guide wire exit port1020, and is sized and shaped to accommodate any desired embolicprotection device, so that the device does not interfere with the guidewire 1100 passing through the guide wire exit port 1020. Thecross-sectional area of the indentation 1012 must be large enough toallow free and easy movement of the filter wire 1104, while preventingretraction or passage of the filter 1102 proximal of the indentation1012. The catheter 1010 can be provided to the physician with the filter1102 or other device preloaded for out-of-the-way, noninterferingstorage during distal advancement of the catheter 1010.

A toroid-shaped insert 1320 constricts or narrows the inner diameter1034 of the catheter 1030 shaft 1036 proximal of the distal exit port1038 and proximal of the guide wire exit port 1040 in FIG. 21A. Thetoroid-shaped insert 1032 may be a thin washer, a short length oftubing, or other alternate structures that allow unencumbered passage offilter wire 1104 yet prevent passage of filter 1102. The walls of theinsert 1320 may be curvilinear overall (forming a “donut” shape), mayform a right cylinder with an axial cylindrical hole, or any othergenerally toroidal shape. In some embodiments the outer diameter of theinsert 1320 is sized and shaped to fit tightly to the catheter shaft1036 inner diameter 1034. Alternatively, toroid insert 1320 may beslightly larger in diameter than catheter shaft 1036 inner diameter 1034and anchored within walls of catheter 1036. The toroid insert 1320 outerdiameter may be secured to the inner diameter 1034 by any suitablepermanent method, such as a press-fit, heat or re-flow bonding, oradhesive bonding. For example, a toroid insert 1320 can be inserted intocatheter shaft 1036 and held at a desired location by mandrels proximaland distal to the insert. The mandrels should be slightly smaller indiameter than catheter inner diameter 1034. The catheter regioncontaining insert 1320 and the mandrels can be inserted into heat shrinktubing and the assembly heated to shrink the heat shrink tubing, meltthe catheter 1036 and cause catheter 1036 inside diameter 1034 toconform to the mandrels, thereby immobilizing insert 1320 into the wallof catheter 1036. The cross-sectional area of the opening through thetoroid 320 must be large enough to allow free and easy passage of thefilter wire 1104, while preventing proximal retraction of the filter1102 through the toroid 1320. The toroid 1320 forms a constriction ornarrowing 1320 of the catheter inner diameter 1034 that creates apreloading stop or “holding zone” location for an embolic protectiondevice, such as an embolic filter 1102. This location is distal of thetoroid 1320 and proximal of the guide wire exit port 1040. The filter1102 or other device can be preloaded for out-of-the-way ornon-interfering storage before and during distal advancement of thecatheter 1030. In FIG. 21A, a second port 1042 can be used as the exitport for the filter wire 1104. This second port is optionallyincorporated into the catheter 1030 and any of the catheter designsdisclosed herein can be comprised of this optional second port.

FIG. 21K shows a detailed view of a toroidal insert 1327 that constrictsor narrows the inner diameter 1034 of the catheter 1030 shaft 1036proximal of the distal exit port 1038 and proximal of the guide wireexit port 1040. Toroidal insert 1327 may be metal, polymer, ceramic,composite, or any other material that creates a preloading stop or“holding zone” location for an embolic protection device, such as anembolic filter 1102. Toroidal insert 1327 may have coaxial inside 3273and outside 3274 diameters (shown), non-coaxial inside 3273 and outside3274 diameters (not shown), and may have irregular inside or outsidediameters. Retaining slot 3271 provides an area for polymer to flow intowhen fusing the insert to the catheter shaft 1036. This flow of polymerinto retaining slot 3271 results in an improved bond to the cathetershaft 1036.

FIG. 21L shows a toroidal insert 1328 that constricts or narrows theinner diameter 1034 of the catheter 1030 shaft 1036 proximal of thedistal exit port 1038 and proximal of the guide wire exit port 1040.Toroidal insert 1328 may be metal, polymer, ceramic, composite, or anyother material that creates a preloading stop or “holding zone” locationfor an embolic protection device, such as an embolic filter 1102.Toroidal insert 1328 may have coaxial inside 3285 and outside 3284diameters (shown), non-coaxial inside 3285 and outside 3284 diameters(not shown), and may have irregular inside or outside diameters.Retaining slot 3281 provides an area for polymer to flow into whenfusing the insert to the catheter shaft 1036. This flow of polymer intoretaining slot 3281 results in an improved bond to the catheter shaft1036. Toroidal insert 1328 is comprised of fingers 3282 and spaces 3283which cooperate with filter wire 1104 and filter 1102 to create apreloading stop or “holding zone” location for an embolic protectiondevice, such as an embolic filter 1102, as described below in connectionwith FIGS. 21D, 21E, and 21M. Toroidal insert 1328 can be made, forexample, by laser cutting a tube or a sheet and is comprised of flexiblemetals such as stainless steel or nitinol, polymers such as polyester,KEVLAR®, or liquid crystal polymers, ceramics, or other materialscapable of elastically deforming without significant deformation in thisapplication.

FIG. 21B shows a tubular insert 1321 that constricts or narrows theinner diameter 1034 of the catheter 1030 shaft 1036 proximal of thedistal exit port 1038 and proximal of the guide wire exit port 1040.Tubular insert 1321 may be metal, polymer, ceramic, composite, or anyother material that creates a preloading stop or “holding zone” locationfor an embolic protection device, such as an embolic filter 1102.Tubular insert 1321 may have coaxial inside and outside diameters,noncoaxial inside and outside diameters, and may have irregular insideor outside diameters. One example of a preferred tubular insert 1321with an irregular inside diameter is shown in FIG. 21F. Tubular insert1321 outer diameter may be secured to the inner diameter 1034 by anysuitable permanent method, such as a press-fit, heat or re-flow bonding,adhesive bonding, or other means as are known in the art.

FIG. 21C shows a catheter 1030 similar in many respects to the catheterof FIG. 21B, however the catheter of FIG. 21C is comprised of cathetershaft reinforcement 1041. Catheter shaft reinforcement 1041 can becomprised of braid, coil, strands, slotted tube, or other shapes thatare fused or otherwise bonded into catheter shaft 1036 for the purposeof providing bending stiffness and axial stiffness (pushability) tocatheter shaft 1036. Catheter shaft reinforcement 1041 can be comprisedof metals such as stainless steel or nitinol, polymers such aspolyester, KEVLAR®, or liquid crystal polymers, ceramics, or othermaterials capable of reinforcing catheter shaft 1036.

FIG. 21D shows catheter 1030 with tubular fingered insert 1322. Tubularfingered insert 1322 is anchored to catheter 1036 as described inconnection with FIG. 21B. Any of the tubular inserts 1321, 1322described herein may optionally be provided with holes 1043 to assistwith anchoring of insert relative to catheter shaft 1036. Insidediameter of fingered insert 1322 may be as smaller than, equal to, orslightly larger than inside diameter 1034 of catheter 1036.

Tubular fingered insert 1322 is shown in greater detail in FIGS. 21E and21M. Fingered insert 1322 is comprised of at least 2 fingers 3221attached to a tubular section 3223 and separated by slots 3225. Tubularsection 3223 is attached to catheter 1036, fingers 3221 are flexible andcan radially flex relative to tubular section 3223. The angle of fingers3221 relative to the central axis of tubular section 3223 can be variedto suit the particular dimensions of catheter 1036, filter wire 1104,and filter 1102 to effect the needed performance. Fingered insert 1322can be made, for example, by laser cutting a tube and is comprised offlexible metals such as stainless steel or nitinol, polymers such aspolyester, KEVLAR®, or liquid crystal polymers, ceramics, or othermaterials capable of elastically deforming without significantdeformation in this application. Tubular fingered insert 1322 iscomprised of end opening 3227 large enough to allow free and easypassage of the filter wire 1104, while preventing proximal retraction ofthe filter 1102 through the fingered insert 1322. Fingered insert 1322can be configured to create a preloading stop or “holding zone” locationfor an embolic protection device, such as an embolic filter 1102.

In use, filter wire 1104 is back loaded through end opening 3227 andfilter wire is advanced proximally until filter 1102 contacts fingers3221. Further proximal advancement of filter 1102 causes fingers 3221 todeflect towards the central axis of catheter 1036 and thereby preventfurther proximal advancement of filter 1102. From this position, distaladvancement of filter 1102 allows deflection of fingers 3221 to reverse,allowing distal movement of filter 1102 and of filter wire 1104 throughend opening 3227.

FIGS. 21G and 21H show catheter 1030 in which the catheter shaft 1036comprises at least two slots 1324 and at least two strips 1326. Strips1326 are displaced radially inwardly relative to catheter shaft 1036axis such that catheter shaft inside diameter 1034 has a constriction1012 of the inside diameter 1034 proximal of both the distal exit port1018 and the guide wire exit port 1040. Constriction 1012 may be formedby applying heat to deform strips 1326 or by other means. Constriction1012 creates a preloading stop or “holding zone” location for an embolicprotection device, such as an embolic filter 1102. The location isdistal of the constriction 1012 and proximal of the guide wire exit port1040, and is sized and shaped to accommodate any desired embolicprotection device, so that the device does not interfere with the guidewire 1100 passing through the guide wire exit port 1040. Thecross-sectional area of the constriction 1012 must be large enough toallow free and easy movement of the filter wire 104, while preventingretraction or passage of the filter 1102 proximal of the constriction1012. The catheter 1030 can be provided to the physician with the filter1102 or other device preloaded for out-of-the-way, non-interferingstorage during distal advancement of the catheter 1030.

FIGS. 21I and 21J show catheter 1030 in which the catheter shaft 1036comprises at least two indentations 1325. Indentations 1325 aredisplaced radially inwardly relative to catheter shaft 1036 axis suchthat catheter shaft inside diameter 1034 has a constriction 1012 of theinside diameter 1034 proximal of both the distal exit port 38 and theguide wire exit port 1040. Constriction 1012 may be formed by applyingheat to deform indentations 1325 or by other means. Constriction 1012creates a preloading stop or “holding zone” location for an embolicprotection device, such as an embolic filter 1102. The location isdistal of the constriction 1012 and proximal of the guide wire exit port1040, and is sized and shaped to accommodate any desired embolicprotection device, so that the device does not interfere with the guidewire 1100 passing through the guide wire exit port 1040. Thecross-sectional area of the constriction 1012 must be large enough toallow free and easy movement of the filter wire 1104, while preventingretraction or passage of the filter 1102 proximal of the constriction1012. The catheter 1030 can be provided to the physician with the filter1102 or other device preloaded for out-of-the-way, non-interferingstorage during distal advancement of the catheter 1030.

In FIGS. 22 and 23, a funnel-shaped member 1052, 1072 provides aconstriction or narrowing of the inner diameter 1054, 1074 of the shaft1056, 1076 of the catheter 1050, 1070, respectively. The funnel-shapedmember 1052, 1072 is proximal of both the distal exit port 1058, 1078and the guide wire exit port 1060, 1080, respectively, and may be madeof metal, polymer, ceramic, composite, or any other material thatcreates a preloading stop or “holding zone” location for an embolicprotection device, such as an embolic filter 1102. The larger outerdiameter of the funnel-shaped member 1052, 1072 is sized and shaped tofit tightly to the catheter shaft 1056, 1076 inner diameter 1054, 1074,respectively. The funnel-shaped member 1052, 1072 outer diameter may beaffixed to the inner diameter 1054, 1074, respectively, by any suitablepermanent method, such as a press-fit, heat or re-flow bonding, oradhesive bonding. For example, funnel-shaped member 1052, 1072 can beinserted into catheter shaft 1056, 1076 and held at a desired locationby mandrels proximal and distal to the member. The mandrels should beslightly smaller in diameter than catheter inner diameter 1054, 1074.The catheter region containing funnel-shaped member 1052, 1072 and themandrels can be inserted into heat shrink tubing and the assembly heatedto shrink the heat shrink tubing, melt the catheter shaft 1056, 1076 andcause catheter shaft 1056, 1076 inside diameter 1054, 1074 to conform tothe mandrels, thereby immobilizing funnel-shaped member 1052, 1072 intothe wall of catheter shaft 1056, 1076. The inner opening of the member1052, 1072 may be funnel-shaped corresponding to the exterior shape ofthe member 1052, 1072. Alternatively, the inner opening may becylindrical or any other suitable shape. The cross-sectional area of theopening of the funnel-shaped member 1052, 1072 must allow free and easypassage of the filter wire 1104, while preventing proximal retraction ofthe filter 102 through the member 1052, 1072.

In the FIG. 22 embodiment 1050, the smaller diameter of thefunnel-shaped member 1052 faces proximally, and in the FIG. 23embodiment 1070, the smaller diameter of the funnel-shaped member 1072faces distally. The funnel-shaped member 1052, 1072 in the catheterinner diameter 1054, 1074, respectively, creates a preloading stop or“holding zone” location for a distal embolic protection device, such asan embolic filter 1102. The filter 1102 or other device can be preloadedto be non-interfering with the guide wire 1100 through the guide wireexit port 1060, 1080.

The embolic protection device delivery/recovery catheter 1090, 1110shown in the FIGS. 24 and 25 embodiments, has a constriction ornarrowing 1092, 1112 in the inner diameter 1094, 1114 of the cathetershaft 1096, 1116 proximal of the distal exit port 1098, 1118 andproximal of the guide wire exit port 1105, 1120, respectively. The axesof the inner diameter 1094, 1114 of the catheter shaft and the innerdiameter 1093, 1113 of the proximal portion of the catheter shaft may besubstantially coaxial as shown in FIGS. 24 and 25 or may be offset andparallel (not shown). The catheter 1090, 1110 is constructed anddesigned for use with any suitable guide wire 1100. The constriction ornarrowing 1092, 1112 of the catheter inner diameter 1094, 1114,respectively, creates a preloading stop or “holding zone” location for adistal embolic protection device, such as an embolic filter 1102. Thislocation is distal of the constriction 1092, 1112 and proximal of theguide wire exit port 1105, 1120, respectively, to prevent interaction ofthe guide wire 1100 with the filter 1102. The guide wire 1100 advancesinto the distal exit port 1098, 1118 and out through the guide wire port1105, 1120, respectively. The catheter 1090, 1110 may have the filter1102 or other device positioned or preloaded for out-of-the-way,non-interfering storage before and during distal advancement of thecatheter 1090, 1110 over a primary guide wire 1100.

The catheter of FIGS. 24 and 25 has the advantage of providingtransverse support to filter wire 1104. It is advantageous to taper thediameter of filter wire 1104 such that the diameter of the filter wire1104 near the filter 1102 is reduced compared to the diameter of thefilter wire 5-20 cm proximal to the filter 1102. Filter wires so taperedcan buckle when they are used to distally advance a filter out of acatheter such catheter 1090, 1110 respectively. By reducing the innerdiameter 1093, 1113 of the proximal portion of the catheter shaft 1096,1116 respectively, lateral support is provided to a tapered filter wire1104 during distal advancement of filter 1102 from the catheter. Saidlateral support can help prevent filter wire 1104 buckling.

In FIGS. 24 and 25, the shaft 1096, 1116 of the catheter 1090, 1110 hasan indentation or reduction 1092, 1112 of both the inner 1094, 1114 andouter diameter 1095, 1115 proximal of both the distal exit port 1098,1118 and the guide wire exit port 1105, 1120. In FIG. 24, the proximalside of the indentation 1092 is an abrupt or right-angled corner 1097reduction from the catheter shaft 1096 full diameter, and the distalside of the indentation 1092 is an abrupt or right-angled corner 1099reduction. The inner diameter 1093 of the proximal portion of the shaft1096 is less than the inner diameter 1094 of the distal portion of theshaft. In FIG. 25, the reduction 1112 is a gradual reduction from thecatheter shaft 1116's largest inner diameter 1114. The inner diameter1113 of the proximal portion of the shaft 1116 is less than the innerdiameter 1114 of the distal portion of the shaft.

The reduction or indentation 1092, 1112 creates a preloading stop or“holding zone” location for a distal embolic protection device, such asan embolic filter 1102. The location is distal of the reduction 1092,1112 and proximal of the guide wire exit port 1105, 1120, and is sizedand shaped to accommodate any desired distal embolic protection deviceor other device, so that the device does not interfere with the guidewire 1100 passing through the guide wire exit port 1105, 1120. Thecross-sectional area of the indentation 1092, 1112 at its narrowestpoint must be large enough to allow free and easy movement of the filterwire 1104, while preventing retraction or passage of the filter 1102proximal of the indentation 1092, 1112. The catheter 1090, 1110 can beprovided to the physician with the filter 1102 or other device preloadedfor out-of-the-way, non-interfering storage during distal advancement ofthe catheter 1090, 1110.

The embolic protection device delivery/recovery catheter 1130 shown inFIGS. 26A and 26B has a constriction or narrowing 1132 in the innerdiameter 1094 of the catheter shaft 1096 proximal of the distal exitport 1098 and proximal of the guide wire exit port 1105. The axes of theinner diameter 1094 of the catheter shaft and the inner diameter 1093 ofthe proximal portion of the catheter shaft are offset and substantiallyparallel. The catheter 1130 is constructed and designed for use with anysuitable guide wire 1100. The constriction or narrowing 1132 of thecatheter inner diameter 1094 creates a preloading stop or “holding zone”location for a distal embolic protection device, such as an embolicfilter 1102. This location is distal of the constriction 1132 andproximal of the guide wire exit port 1105 to prevent interaction of theguide wire 1100 with the filter 1102. The guide wire 1100 advances intothe distal exit port 1098 and out through the guide wire port 1105. Thecatheter 1130 may have the filter 1102 or other device positioned orpreloaded for out-of-the way, non-interfering storage before and duringdistal advancement of the catheter 1130 over a primary guide wire 1100.

Additionally, the embolic protection device delivery/recovery catheter1130 shown in FIGS. 26A and 26B, has a stiffening member 1134 embeddedin wall of catheter 1096. Stiffening member 1134 may comprise metal,polymer, ceramic, composite, or any other material that imparts bendingstiffness and columnar stiffness to proximal portion of catheter shaft1096 for the purpose of improved catheter pushability and trackabilitythrough the vasculature of a patient. By way of example, catheter shaft1096 may be comprised of a two lumen extrusion as shown in FIG. 26B withstiffening member 1134 within one of the lumens. Distal portion 1136 ofcatheter 1096 may be a single lumen tube attached to two lumen tube ofcatheter 1096 by heat fusing by means of mandrels and heat shrink tubingin a manner similar to that described above in connection with FIG. 21Ausing methods well known to those of skill in the art.

The embolic protection device delivery/recovery catheter 1150 shown inFIGS. 26C and 26D has a constriction or narrowing 1152 in the innerdiameter 1094 of the catheter shaft 1096 proximal of the distal exitport 1098 and proximal of the guide wire exit port 1105. The axes of theinner diameter 1094 of the catheter shaft and the inner diameter 1093 ofthe proximal portion of the catheter shaft are offset and substantiallyparallel. The catheter 1150 is constructed and designed for use with anysuitable guide wire 1100. The constriction or narrowing 1152 of thecatheter inner diameter 1094 creates a preloading stop or “holding zone”location for a distal embolic protection device, such as an embolicfilter 1102. This location is distal of the constriction 1152 andproximal of the guide wire exit port 1105 to prevent interaction of theguide wire 1100 with the filter 1102. The guide wire 1100 advances intothe distal exit port 1098 and out through the guide wire port 1105. Thecatheter 1150 may have the filter 1102 or other device positioned orpreloaded for out-of-the way, non-interfering storage before and duringdistal advancement of the catheter 1150 over a primary guide wire 1100.

The catheter of FIGS. 26A to 26D has the advantage of providingtransverse support to filter wire 1104. It is advantageous to taper thediameter of filter wire 1104 such that the diameter of the filter wire1104 near the filter 1102 is reduced compared to the diameter of thefilter wire 5-20 cm proximal to the filter 1102. Filter wires so taperedcan buckle when they are used to distally advance a filter out of acatheter such catheter 1130, 1150 respectively. By reducing the innerdiameter 1093 of the proximal portion of the catheter shaft 1096,lateral support is provided to a tapered filter wire 1104 during distaladvancement of filter 1102 from the catheter. Said lateral support canhelp prevent filter wire 1104 buckling.

Additionally, the embolic protection device delivery/recovery catheter1150 shown in FIGS. 26C and 26D, has a stiffening member 1154 embeddedin wall of 1010 catheter 1096. Stiffening member 1134 may comprisemetal, polymer, ceramic, composite, or any other material that impartsbending stiffness and columnar stiffness to proximal portion of cathetershaft 1096 for the purpose of improving catheter pushability andtrackability through the vasculature of a patient. By way of example,catheter shaft 1096 may be comprised of a heat shrink tubing as shown inFIG. 26D with stiffening member 1134 and catheter shaft within the lumenof the heat shrink tubing 1156 and held in close apposition thereby.

The embolic protection device delivery/recovery catheter 1170 shown inFIGS. 27A to 27D has a constriction or narrowing effected by toggle 1172in the inner diameter 1094 of the catheter shaft 1096 proximal of thedistal exit port (not shown) and proximal of the guide wire exit port(not shown). The axes of the inner diameter 1094 of the catheter shaftand the effective inner diameter 1093 of the proximal portion of thecatheter shaft are offset and substantially parallel. The catheter 1170is constructed and designed for use with any suitable guide wire 1100.The constriction or narrowing effected by toggle 1172 creates a preloading stop or “holding zone” location for a distal embolic protectiondevice, such as an embolic filter 1102. This location is distal of theconstriction effected by toggle 1172 and proximal of the guide wire exitport to prevent interaction of the guide wire 1100 with the filter 1102.The guide wire 1100 advances into the distal exit port and out throughthe guide wire port. The catheter 1170 may have the filter 1102 or otherdevice positioned or preloaded for out-of-the-way, non-interferingstorage before and during distal advancement of the catheter 1170 over aprimary guide wire 1100.

Additionally, the embolic protection device delivery/recovery catheter1170 shown in FIGS. 27A to 27D has a distal diameter reduced portion1182 of catheter 1096. Diameter reduced portion 1182 of catheter 1096may be formed by necking, swaging, or other means as are known in theart. Diameter reduced portion 1182 of catheter 1096 advantageouslyprovides a reduced lesion crossing profile to catheter 1096. Any of thecatheters described herein may be comprised of diameter reduced portion1182.

Toggle 1172 and toggle pivot 1174 may comprise metal, polymer, ceramic,composite, or any other material that has enough strength to preventpassage of filter proximally past toggle 1172. Toggle pivot is embeddedin catheter 1096 within pocket 1176. Pocket 1176 allows toggle to moverelatively freely about toggle pin 1174. Catheter 1096 may be reinforced(not shown), for example with metals, in the vicinity of toggle pin toprevent toggle pin 1174 from tearing out of catheter 1096 during use.

Toggle 1172 effects a constriction or narrowing and thereby creates apreloading stop or “holding zone” location for a distal embolicprotection device, such as an embolic filter 1102 as follows. Filterwire is back loaded into distal exit port (not shown) and past toggle1172 as shown in FIG. 27C. As filter wire 1104 traverses toggle 1172toggle will pivot, allowing filter wire 1104 to pass through effectiveinner diameter 1093. Further proximal advancement of filter wire 1104will cause enlarged proximal end of filter 1106 to contact distal face1178 of toggle, and still further proximal advancement of filter wire1104 will cause causing toggle 1172 to pivot about toggle pin 1174 anddecrease effective inner diameter 1093 by moving proximal toggle arm1177 towards the opposing wall 1175 of catheter 1096. Proximaladvancement of filter wire 1104 will cease when enlarged proximal end offilter 1106 contacts proximal toggle arm 1177.

The following general details of the construction and operation of theinventive catheter apply to all embodiments, with specific details forindividual embodiments as noted. Preferably, the catheter of thisinvention has a guide wire exit port located from 5 to 30 cm from thecatheter distal tip. Proximal of the guide wire exit port is aconstriction that creates a reduction of the size of the inner diameterof the catheter shaft. The distance between the guide wire exit port andthe constriction can be made to accommodate the size and shape of thespecific distal embolic protection device or other device to beretained.

The catheter inner diameter can be reduced or necked down by anysuitable configuration of the overall cross-sectional area that willpermit unimpeded passage for a distal embolic protection device wire,while preventing retraction of the device proximal of the constriction.The constriction or diameter reduction can be abrupt, gradual ortapered, or any combination or multiple series of abrupt or gradualtapers or reductions. Additional non-limiting examples of the desiredconstriction include indentations or dimples within the catheter wall,an intraluminal net or meshwork, or use of a pin transverse to thecatheter axis. Additional guide wire exit port(s) may be locatedproximal of this constriction or diameter reduction.

An exemplar use of the catheters described herein is as follows. A guidecatheter is introduced from the groin of the patient, through thefemoral artery, and to the ostium of a coronary vessel as previouslydescribed and as is well known in the art. A coronary guidewire isthreaded through the guidewire and into a coronary vessel to a region ofinterest. An embolic protection device filter wire 1104 is back loadedinto the distal exit port of an inventive catheter, through theconstriction or narrowing, and proximally through the inventivecatheter. The filter wire is advanced proximally until the filter 1102is positioned or pre-loaded within the catheter and abuts the distalportion of the constriction or narrowing in a preloaded, out-of-the-way,non-interfering storage position. The coronary guidewire is next backloaded into the distal exit port of an inventive catheter and out of thecatheter through the guide wire port located distal to the constrictionor narrowing. Next the inventive catheter is advanced distally along theguidewire to a region of interest. The guidewire is withdrawn from thepatient and catheter is withdrawn proximally relative to the embolicfilter 1102, whereby the filter deploys or is deployed and the inventivecatheter is withdrawn from the patient.

To recover the embolic device the proximal end of the filter wire 1104is back loaded into the distal exit port of an inventive catheter andthe catheter advanced distally to the immediate proximity of the filter.The filter is then drawn into the inventive catheter and the inventivecatheter removed from the patient.

The catheter of this invention provides many advantages for thephysician and the patient. The catheter inner diameter constrictionprovides a location to preload an embolic protection device and allowsthe physician to use a guide wire of choice to position the catheterintravascularly. Typical over-the-wire or rapid-exchange catheterdesigns may allow a physician to use a favored guide wire for catheterpositioning, but do not provide a preloaded device in a non-interferingposition, as does the present catheter. The catheter may be constructedto accept any type, shape or size of embolic protection device or otherdevice. The physician may obtain the catheter with a pre-loaded deviceof choice. The use of the catheter with a preloaded device reduces thedistance the catheter must travel, in comparison to a conventionaldelivery/recovery catheter, thus reducing intravascular manipulation byreducing the number of catheter exchanges, lessening trauma to thepatient, and the length of time for the procedure. The catheter with apreloaded device allows correct positioning of the embolic device everytime, while preventing interaction of the guide wire with the device.The present catheter improves overall ease of use both in constructionof the catheter, in positioning the catheter within the patient, and indeploying the embolic protection device.

The above description and the drawings are provided for the purpose ofdescribing embodiments of the invention and are not intended to limitthe scope of the invention in any way. It will be apparent to thoseskilled in the art that various modifications and variations can be madewithout departing from the spirit or scope of the invention. Thus, it isintended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

The invention claimed is:
 1. A catheter for the intravascular deploymentof a medical device, the catheter comprising: an elongate tubular bodyhaving a proximal portion, a distal portion, a proximal end, and adistal end, wherein the elongate tubular body defines a lumen extendingbetween the proximal end and the distal end; wherein the distal portionof the elongate tubular body defines a first port formed through a tubewall of the elongate tubular body into the lumen at the distal portion,wherein the first port is disposed proximal to the distal end of theelongate tubular body, wherein the first port is dimensioned to receivea guide wire therethrough, and wherein the lumen defines a first innerdiameter at the first port and a second inner diameter less than thefirst inner diameter at a position proximal to the first port; andwherein the distal portion comprises a transition point proximal to thefirst port at which the diameter of the lumen transitions from the firstinner diameter to the second inner diameter.
 2. The catheter of claim 1,wherein the tube wall of the elongate tubular body has a substantiallyuniform wall thickness.
 3. The catheter of claim 1, wherein atoroid-shaped insert is disposed in the lumen of the elongate tubularbody perpendicular to a longitudinal axis of the lumen at the transitionpoint to reduce the lumen from the first inner diameter to the secondinner diameter.
 4. The catheter of claim 3, wherein the toroid-shapedinsert is a washer.
 5. The catheter of claim 1, wherein a funnel-shapedinsert is disposed in the lumen of the elongate tubular body along alongitudinal axis of the lumen at the transition point to reduce thelumen from the first inner diameter to the second inner diameter.
 6. Thecatheter of claim 5, wherein the funnel-shaped insert has a largeropening directed towards the distal end of the elongate tubular body. 7.The catheter of claim 1, wherein the lumen of the elongate tubular bodyhas the second inner diameter extending over a substantial portion ofthe elongate tubular body along a longitudinal axis of the lumen.
 8. Thecatheter of claim 1, wherein the elongate tubular body comprises anabrupt reduction in inner diameter at the transition point from thefirst inner diameter to the second inner diameter.
 9. The catheter ofclaim 1, wherein the elongate tubular body comprises a gradual reductionin inner diameter at the transition point from the first inner diameterto the second inner diameter.
 10. The catheter of claim 1, wherein theelongate tubular body defines a second port formed through the tube wallof the elongate tubular body into the lumen at the distal portion of theelongate tubular body and proximal to the transition point, wherein thesecond port is configured to receive a host wire for the medical device.11. The catheter of claim 10, wherein the second port is disposed from 5to 20 centimeters proximal of the first port.
 12. The catheter of claim1, wherein the first port is disposed from 5 to 30 centimeters from thedistal end of the elongate tubular body.
 13. The catheter of claim 1,wherein the first port has a maximum dimension of less than 0.040 inch.14. The catheter of claim 1, wherein the first port has a maximumdimension of less than 0.020 inch.
 15. The catheter of claim 1, whereinthe catheter has an outer diameter of less than 0.040 inch.
 16. Anassembly comprising: the catheter of claim 1; and a host wire comprisingan embolic protection device at one end, wherein the embolic protectiondevice is disposed within the lumen of the elongate tubular body distalto the transition point and proximal to the first port; wherein thetransition point and the embolic protection device are sized to preventthe embolic protection device from moving proximally across thetransition point.
 17. The assembly of claim 16, wherein the elongatetubular body defines a second port formed through the tube wall of theelongate tubular body into the lumen at the distal portion of theelongate tubular body and proximal to the transition point, wherein thehost wire extends through the second port.
 18. The assembly of claim 16,wherein the distal portion of elongate tubular body comprises a deliverysheath configured to deliver the embolic protection device through thedistal end of the elongate tubular body, and wherein the proximalportion of the elongate tubular body comprises a retrieval sheathconfigured to receive the embolic protection device through the proximalend after being delivered through the distal end.
 19. The assembly ofclaim 18, wherein the proximal portion of the elongate tubular bodydefines a third port formed through the tube wall of the elongatetubular body into the lumen, wherein the third port is configured toreceive the host wire during the retrieval of the embolic protectiondevice through the proximal end.
 20. The catheter of claim 1, whereinthe distal portion of elongate tubular body comprises a delivery sheathconfigured to deliver an embolic protection device through the distalend of the elongate tubular body, and wherein the proximal portion ofthe elongate tubular body comprises a retrieval sheath configured toreceive the embolic protection device through the proximal end afterbeing delivered through the distal end.